The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the PCSK9 inhibitor evolocumab to reduce CV risk in patients with established atherosclerotic CVD (myocardial infarction [MI], stroke, or peripheral arterial disease). Evolocumab is a human monoclonal antibody that inhibits PCSK9 and results in the lowering of LDL-c levels.

This opinion is based on the findings from the FOURIER trial, including 27564 patients, that showed that evolocumab op top of maximally tolerated statin therapy resulted in a 15% reduction of the primary endpoint, including hospitalization for unstable angina, coronary revascularization, MI, stroke or CV death, compared to patients treated with placebo and statin therapy. In addition, a 20% reduction in MACE, a composite of time to first MI, stroke or CV death, was observed in the evolocumab-treated group.

The European Commission (EC) will now review the CHMP opinion and if they decide to approve evolocumab to reduce CV risk in high-risk patients, this will result in EU marketing authorization of the drug. Norway, Iceland and Liechtenstein will take corresponding decisions based on the EC’s decision.

The U.S. Food and Drug Administration (FDA) approved a new indication for evolocumab to prevent MIs, strokes and coronary revascularizations in adults with established CVD on Dec 1, 2017.